FreezeKit Cleave , ThawKit Cleave

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Freezekit Cleave , Thawkit Cleave.

Pre-market Notification Details

Device IDK150950
510k NumberK150950
Device Name:FreezeKit Cleave , ThawKit Cleave
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB 3601 SOUTH INCA STREET Englewood,  CO  80110
ContactBrett Sonet Glazar
CorrespondentBrett Sonet Glazar
VITROLIFE SWEDEN AB 3601 SOUTH INCA STREET Englewood,  CO  80110
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-08
Decision Date2015-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350025910710 K150950 000
07350025910703 K150950 000

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